MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT

Catalog Number ZIV6-35-125-6-80-PTX

Device Problem Occlusion Within Device (1423)

Patient Problem Occlusion (1984)

Event Date 10/20/2014

Event Type  Injury  

Manufacturer Narrative

The zilver ptx device involved in this complaint was implanted in the patient therefore is not available for evaluation.With the information provided, a document based investigation was carried out.It may be noted that re-stenosis is a common adverse event of endovascular procedures and can be caused by injury to the vessel (e.G.During pta and/or stenting).Vessel injury provokes an inflammatory response that leads (or amplifies) to the restenosis process.As per instructions for use, restenosis of the stented artery is noted as a potential adverse event associated with the placement of this device.Images relating to this event were received and reviewed as follows: findings: angiography from implantation (b)(6) 2014 is provided.The initial lesion was moderate stenosis of the proximal third left sfa first treated with angioplasty and then treated with two 6x80 zilver ptx stents.The stenosis was treated with pta before and after stent placement.Total stented length was 15cm with one cm over overlap.A subtle dissection non-flow limiting dissection was present at the lateral margin of the distal ptx stent extending 1.5cm more inferior into the sfa.No residual in-stent stenosis was present.No inflow stenosis was present.One vessel runoff via the posterior tibial artery was present to the foot.On (b)(6) 2014, a left leg angiogram demonstrated stent and sfa occlusion beginning one cm superior the proximal ptx stent, extending through the stents, and ending 6cm inferior the distal ptx stent.The occlusion was cross with a cxi catheter.Guide wire manipulation demonstrated a moderate proximal stenosis.After the occlusion was crossed an emboshield embolic protection device was placed in the popliteal artery and angioplasty of the occlusion performed alongside the emboshield wire over a tandem wire.Post angioplasty angiography demonstrated hemodynamically significant recoil with a slight dissection beginning at the distal ptx stent inferior margin and extending two centimeters.The stenosis was most severe in the center of the 2cm segment.This was treated with a supera stent placed over the emboshield wire.Angioplasty had improved the moderate, 70-40 percent, proximal zilver ptx in-stent stenosis to mild, less than 40 percent stenosis.This was stented over the emboshield wire after additional angioplasty with a 6x100 zilver ptx extended slightly into the cfa.The mild residual stenosis did not significantly improve after stenting and post stent angioplasty.No filling defects were evident in the emboshield.It was removed and a final selective left leg runoff performed.This demonstrated the mild residual proximal stenosis, the additional stents, and progressive diffuse atherosclerotic disease of the posterior tibial and peroneal arteries.The left anterior tibial artery was chronically occluded.Impression: no angiography inside occluded segment was provided.However, the proximal neointimal hyperplasia causing the ptx stenosis was demonstrated to be only moderate by guide wire manipulation.After angiography, recoil of the stenosis distal the ptx stents revealed that this had been the only angiographically significant lesion.Had the ptx intimal hyperplasia been primarily responsible, the right sfa stents would have thrombosed before the left.Therefore occlusion was primarily the result of sfa disease progression distal the ptx stents and not the ptx intimal hyperplasia.Atherosclerotic disease was progressive not only in the sfa but also in the calf which demonstrates that this was not just a function of a adjacent stent but also of progressive atherosclerotic disease and the mild post stent dissection.It was noted that pre-existing condition of peripheral artery disease may have caused and/or contributed to this adverse event.According to the independent image review, occlusion was primarily the result of sfa disease progression and not the ptx intimal hyperplasia.However the definite root cause cannot be determined.The complaint was confirmed based on customer testimony.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

(b)(6).Two 6x80 zilver ptx stents implanted in the study lesion.Re-intervention in the study lesion due to occlusion/re-stenosis, treated by pta and stent placement on (b)(6) 2014.Physician states that the current adverse event was "possibly" related to the study product and procedure.Also, it was noted that the pre-existing condition of peripheral artery disease may have caused or contributed to this adverse event.This patient was discharged from the hospital on (b)(6) 2014.No further adverse effects to the patient have been reported as occurring.Reference related report 3001845648-2014-00247.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid, senior specialist ; EI
• MDR Report Key: 4283334
• MDR Text Key: 49754498
• Report Number: 3001845648-2014-00246
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002248905
• UDI-Public: (01)10827002248905(17)140216(10)C944560
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100022/S001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2014
• Device Catalogue Number: ZIV6-35-125-6-80-PTX
• Device Lot Number: C944560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/20/2014
• Event Location: Hospital
• Date Manufacturer Received: 10/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR